iPLEDGE: risk management program on isotretinoin

Filed in archive Miscellany on February 27, 2006

Accutane (and its generics) containing the active ingredient isotretinoin is a drug that is used to treat severe recalcitrant nodular acne but carries a significant risk of birth defects if taken during pregnancy.

On March 1, a strengthened risk management program to educate women about the risk of becoming pregnant while taking isotretinoin will be implemented. Called the iPLEDGE program, is a comprehensive program seeking to reduce the risk of inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin.

The iPLEDGE program is a unique risk management program that is unprecedented in size and scope. It has been developed through a cooperative effort of several manufacturers of isotretinoin, a drug that has been marketed for several decades.

FDA has worked closely with isotretinoin sponsors and their vendor, Covance Inc., to maintain a critical balance between access to the drug by patients who need it and ensuring its safe use. In response to concerns about the operational aspects of the program raised by dermatologists and pharmacists in recent weeks, FDA has ensured that rapid and significant progress has been made by the sponsors and Covance to address them.

If you are pregnant or will be pregnant, then you should not use isotretinoin. The iPLEDGE program is aimed at preventing use of the drug during pregnancy. In order to obtain the drug, after registering with iPLEDGE, patients must comply with a number of important requirements that include completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and, for women of childbearing age, complying with necessary pregnancy testing.

Source: [US FDA]